Will Charlton, M.D., M.A.S.,
Polaryx Therapeutics, Inc. (Nasdaq: PLYX) has appointed Will Charlton, M.D., M.A.S., as chief medical officer, strengthening its clinical leadership as the Paramus, New Jersey-based biotechnology company prepares to initiate its Phase 2 SOTERIA trial in the fourth quarter of 2026
Charlton brings nearly two decades of experience as a chief medical officer and clinical development executive, with a focus on rare diseases and pediatric drug development. A board-certified pediatric endocrinologist, he will help lead the clinical strategy for Polaryx’s lead drug candidate, PLX-200, as the company moves toward a significant stage in its development program
The appointment comes as Polaryx shifts its focus toward clinical execution across multiple lysosomal storage disorders, or LSDs. Its planned SOTERIA study is a Phase 2, open-label, single-arm basket trial evaluating the safety, tolerability and clinical activity of PLX-200 in patients with CLN2, CLN3, Krabbe disease and Sandhoff disease. Polaryx estimates that patients with those four disorders represent roughly one-quarter of the LSD population
Charlton most recently served as senior vice president of clinical development for skeletal dysplasia at Tyra Biosciences. In that position, he led a Phase 2 rare disease clinical trial program through key milestones and developed a multi-indication clinical development plan supporting the company’s longer-term strategy
Previously, he was chief medical officer at Spruce Biosciences, where his responsibilities included redesigning and optimizing the clinical development strategy for congenital adrenal hyperplasia, a rare inherited genetic disorder caused by an enzyme deficiency, with an emphasis on pediatric patients. He has also held senior medical director and clinical development positions at 89bio, Ascendis Pharma and Allergan
Charlton said Polaryx’s preclinical work and the established safety profile supporting PLX-200 were important factors in his decision to join the company. He said his experience as both a pediatrician and clinical development executive has provided firsthand exposure to the unmet needs facing rare disease patients and the difficulties involved in bringing new therapies to pediatric populations
CEO Alex Yang said Charlton’s combination of rare disease trial leadership, chief medical officer experience and pediatric clinical practice makes him well suited to oversee the SOTERIA program. With the study targeted to begin during the fourth quarter, the appointment adds clinical development experience at a point when Polaryx is moving from preclinical validation toward broader human testing of its lead candidate
The FDA issued Polaryx a safe-to-proceed letter for SOTERIA in October 2025. The company plans to open trial sites initially in the United States, followed by sites in other jurisdictions
SOTERIA’s basket-trial structure is intended to generate clinical evidence for PLX-200 across several rare disorders through a single development program. While the study is open label, its CLN2 and CLN3 cohorts will include analyses comparing patients receiving PLX-200 with natural history data. Those observational datasets track how diseases progress without the investigational treatment and can provide a reference for evaluating clinical outcomes
Data from the study are expected to help Polaryx determine PLX-200’s subsequent development pathway, including the potential design of pivotal trials. The company has also said it could pursue an expedited approval pathway if the clinical results demonstrate sufficiently compelling activity
Polaryx, founded in 2014, is developing small-molecule and gene therapies for rare orphan lysosomal storage disorders. Its development strategy includes small-molecule candidates, a combination therapy and a gene therapy designed to address genetic and downstream pathological characteristics associated with LSDs. PLX-200 is its most advanced program
Before moving into biotechnology drug development, Charlton spent more than a decade practicing as a pediatric endocrinologist. He currently serves on the board of ReSurge International, a nonprofit focused on expanding access to reconstructive surgical care in underserved regions
Charlton earned his medical degree from the University of Southern California Keck School of Medicine and completed his pediatric internship and residency at Children’s Hospital Los Angeles. He later completed a Master of Advanced Studies in Clinical Research and a pediatric endocrinology fellowship at the University of California, San Francisco. He also holds a bachelor’s degree in Liberal Studies from the University of the Pacific and is licensed by the Medical Board of California
